could be tomorrow morning
Precision Medicine; Targeted Therapeutics, Novel Therapeutic Modalities
Recent Developments in the treatment of Melanoma
Adil Daud, MD, Director, Melanoma Clinical Research, UCSF Helen Diller Family Comprehensive Cancer Center, University of California San Francisco School of Medicine
He's the real deal.
Monday, September 16, 2013
The FDA has granted Priority Review designation to dabrafenib (Tafinlar) and trametinib (Mekinist) as a combination treatment for patients with unresectable or metastatic melanoma with a BRAFV600E/K mutation.
According to a statement from the drugs’ manufacturer, GlaxoSmithKline, the FDA has set target dates in early January 2014 to review the trametinib and dabrafenib supplements. The drugs were approved simultaneously as single-agents earlier this year.
Each drug treats melanoma through a different mechanism of action. Dabrafenib is a BRAF inhibitor approved to treat patients who express the BRAFV600E mutation, while trametinib, a MEK 1/2 inhibitor is approved to treat patients with either the BRAFV600E or BRAFV600K mutation. Both drugs act on the RAS kinase pathway, dabrafenib at an earlier point than trametinib. A patient will typically develop resistance to dabrafenib monotherapy after about 5 to 7 months. The addition of trametinib helps overcome the tumor’s resistance mechanism, allowing for a more durable response to treatment
The Priority Review was granted based on the results of a randomized phase I/II study that compared combination therapy with dabrafenib and trametinib to dabrafenib monotherapy in adult patients with BRAFV600E/K mutation-positive metastatic melanoma.
According to the study that was published in the New England Journal of Medicine, progression-free survival (PFS), response rate, and duration of response favored the combination of dabrafenib and trametinib compared to single-agent dabrafenib for patients with BRAFV600E/K –positive metastatic melanoma.
The phase II study randomized 162 patients with BRAFV600E/K –positive metastatic melanoma to one of three treatment arms: monotherapy with dabrafenib at 150 mg/BID; combination of dabrafenib at 150 mg/BID plus 1 mg of once-daily trametinib; or concurrent full doses of both drugs (dabrafenib at 150 mg/BID; once-daily trametinib at 2 mg). The median PFS for patients who received the full dose combination was 9.4 months, as compared with 5.8 months with dabrafenib monotherapy (hazard ratio for progression or death, 0.39; 95% confidence interval, 0.25 to 0.62; P
Updated Oct 3rd 2013 6:20AM
OncoSec Medical to Present at the 12 th Annual BIO Investor Forum
SAN DIEGO--(BUSINESS WIRE)-- OncoSec Medical Inc. (OTCQB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumors, has announced it will be presenting at the 12th Annual BIO Investor Forum.
Punit Dhillon, President and CEO of OncoSec Medical, will provide a company overview and will be available to participate in one-on-one meetings with investors who are registered to attend the conference.
The presentation will take place on Tuesday, October 8 at 2:30 p.m. PT in the Presidio room at the Palace Hotel in San Francisco, California. The presentation will also be webcast and can be viewed at this link:
A webcast replay will be available one hour after the conclusion of the live event and will expire on January 7, 2014.
10th International Bioelectrics Symposium (BIOELECTRICS 2013) at Karlsruhe Institute of Technology (KIT), Germany, in September 16-19, 2013.
This conference targets to an open information exchange on latest findings and developments in the field of Bioelectrics, i.e. the interaction of Pulsed Electric Fields and Plasma with biological cells and tissue. Oral and poster presentations will focus on the following generalized topics:
Pulsed Electric Fields in Bioelectrics, Basic Research and Applications
Plasma in Bioelectrics, Basic Research and Applications
Industrial, Environmental and Medical applications of Bioelectrics
Pulsed Power Technology and Diagnostics for Bioelectrics
Special emphasis will be addressed to: Environmental and biomass processing applications of Electroporation
on Tuesday September 17th - 10:45-11:05 Gene Electrotransfer for the Effective Immunotherapy of Melanoma ..................................
Richard Heller*; Cathryn Lundberg; Niculina Burcus and Shawna Shirley
other interesting ones- P-I-08 Additional data on the combination of bleomycin and cell membrane electroporation .......
Isabelle Leray*, Mattia Ronchetti, Ruggero Cadossi ,Lluis M. Mir
P-I-02 Calcium electroporation for treatment of cutaneous metastases; Design of a randomised double-blind phase II clinical trial. ...................................................................
Hanne Falk Hansen*, Julie Gehl
10:45-11:05 Electrochemotherapy: Present clinical use and future prospects..........................................
Julie Gehl *
16:45-17:05 Nanosecond Pulsed Electric Field (nsPEF) Inhibits Pancreatic Cancer via Repressing NF-B and Wnt/-Catenin Signaling Pathway in vitro ..........................................................
Zhigang Ren*, Xinhua Chen, Shengyong Yin, Lin Zhou, Shusen Zheng
Calcium Electroporation for the Treatment of Cutaneous Metastases
By on Friday, September 13th, 2013
Condition : Cutaneous Metastases Interventions : Drug: Calcium electroporation; Drug: Electrochemotherapy with bleomycin Sponsors : Herlev Hospital; Herlev Hospital Recruiting – verified September 2013
More info -
Assessment of delivery parameters with the multi-electrode array for development of a DNA vaccine against Bacillus anthracis
Amy Donatea, b, , , Richard Hellerb, ca University of South Florida, College of Medicine, 12901 Bruce B. Downs Blvd., Tampa, FL 33612, USA
b Old Dominion University, Center for Bioelectrics, 4211 Monarch Way, Suite 300, Norfolk, VA 23508, USA
c Old Dominion University, College of Health Sciences, School of Medical Laboratory and Radiation Sciences, 5115 Hampton Boulevard, Norfolk, VA 23508, USA
Received 26 October 2012Revised 18 April 2013Accepted 19 April 2013Available online 26 April 2013
•MEA delivery at 25 and 35 V significantly increase antibodies compared to IO.
•No significant differences were seen from adding additional treatments.
•No significant differences were seen from increasing amount of plasmid.
•Results were similar when compared to muscle gene electrotransfer groups.
•Neutralizing antibodies were induced from MEA delivery at 25 and 35 V.
Gene electrotransfer (GET) enhances delivery of DNA vaccines by increasing both gene expression and immune responses. Our lab has developed the multi-electrode array (MEA) for DNA delivery to skin. The MEA was used at constant pulse duration (150 ms) and frequency (6.67 Hz). In this study, delivery parameters including applied voltage (5–45 V), amount of plasmid (100–300 μg), and number of treatments (2−3) were evaluated for delivery of a DNA vaccine. Mice were intradermally injected with plasmid expressing Bacillus anthracis protective antigen with or without GET and αPA serum titers measured. Within this experiment no significant differences were noted in antibody levels from varying dose or treatment number. However, significant differences were measured from applied voltages of 25 and 35 V. These voltages generated antibody levels between 20,000 and 25,000. Serum from animals vaccinated with these conditions also resulted in toxin neutralization in 40–60% of animals. Visual damage was noted at MEA conditions of 40 V. No damage was noted either visually or histologically from conditions of 35 V or below. These results reflect the importance of establishing appropriate electrical parameters and the potential for the MEA in non-invasive DNA vaccination against B. anthracis.
I just posted info on the INO board.
That is the issue it will appear in. It is available now online.
Volume 94, December 2013, Pages 1–6
In this study we have evaluated the appropriate parameters necessary for inducing humoral immunity from a MEA delivered DNA vaccine against B. anthracis. We evaluated the necessary dosage and GET conditions for the development of antibody responses and toxin neutralizing activity. Our results showed no significant differences in antibody levels from altering amount of plasmid or number of treatments; however, significant increases were noted with the MEA at particular GET voltages (25 and 35 V) as compared to IO. The results were similar to those obtained from muscle GET samples without needing to penetrate the skin during GET administration. Histological assessment of the skin showed no damage from treatment as compared to IO, but did show an increase in infiltrate which may provide additional immunity not demonstrated by antibody responses. Additionally, we demonstrated the importance of considering the desired outcome for the evaluation of electrode design. This was expressly shown where high gene expression (4PE or MEA at 40 V) did not correlate to high antibody levels. Given this information, the MEA should be considered a possible alternative to invasive GET devices when used with appropriate conditions. Future applications with the MEA should also evaluate the presence of a cellular immune response.